The National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health, has awarded eight contracts
to strengthen and expand its nationwide group of institutions conducting
clinical trials of promising candidate vaccines and therapies for
infectious diseases. In addition to increasing the number of sites
from seven to eight, NIAID expects the Vaccine and Treatment Evaluation
Units (VTEUs) to carry out more clinical trials in larger populations
and to safely test vaccines in specific vulnerable populations,
such as infants and the elderly. Moreover, all the VTEUs will have
inpatient beds for isolating volunteers who participate in the
testing of vaccines containing weakened versions of live microbes,
making it easier to conduct such trials quickly.

Each VTEU will receive approximately $23.7 million over seven
years. The combined capabilities of these research facilities — located
in Atlanta, Baltimore, Cincinnati, Houston, Iowa City, Nashville,
Seattle and St. Louis — will enhance NIAID’s ability to direct clinical
research to quickly respond to emerging public health needs.

"In more than four decades of research, the VTEUs have conducted
hundreds of clinical trials of investigational vaccines and therapeutics
for a variety of infectious diseases of public health concern,
and many of these trials have contributed to the licensure of products," says
NIAID Director Anthony S. Fauci, M.D. "We expect this success to
continue, as each VTEU has exceptional expertise and experience
in vaccinology and an impressive capacity to recruit volunteers
from diverse populations in its community."

Established in 1962, the VTEUs are a national resource for vaccine
development. VTEU investigators have tested and advanced vaccines
for many diseases, including influenza, pneumonia, whooping cough,
Haemophilus influenzae infection, cytomegalovirus infection, malaria,
smallpox, anthrax and tularemia. Childhood vaccines and combination
vaccines — the delivery of several vaccines through one inoculation — have
been and remain an important part of the VTEUs’ research goals.
The first trial of an edible vaccine was conducted by VTEU researchers,
and other novel vaccine delivery systems have been extensively
tested by this select group of medical research facilities. For
example, one VTEU demonstrated that consuming genetically engineered
potatoes could stimulate an immune response against Escherichia
coli in humans, and six VTEUs enrolled young children in a successful
Phase III trial of FluMist, an influenza vaccine delivered through
a nasal spray.

An important strength of the VTEUs is their ability to enroll
large numbers of volunteers into trials rapidly and vaccinate them
in a manner that is safe, effective and quick to yield results.
This rapid-response capability is especially important for testing
vaccines designed to counteract emerging public health concerns.
For example, the VTEUs conducted multiple studies in 2005 and 2006
of a vaccine for a strain of H5N1 avian influenza virus to determine
the most effective dose. Those studies led to the licensure of
the first vaccine approved by the U.S. Food and Drug Administration
(FDA) against an H5N1 influenza virus. The units also swiftly initiated
a large-scale trial to evaluate the seasonal influenza vaccine
Fluarix for use in healthy adults in the United States. The trial
demonstrated the vaccine’s safety and ability to generate an immune
response and ultimately led to its expedited approval by FDA in
August 2005 — less than a year after the trial began. This approval
helped reduce the impact of future delays or shortages of seasonal
influenza vaccines in the United States.

The selected VTEU sites and principal investigators (PIs) are
as follows.

News releases, fact sheets and other NIAID-related materials
are available on the NIAID Web site at <http://www.niaid.nih.gov>.

NIAID is a component of the National Institutes of Health. NIAID
supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from potential
agents of bioterrorism. NIAID also supports research on basic immunology,
transplantation and immune-related disorders, including autoimmune
diseases, asthma and allergies.

The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.